Comparison of Bond Failure with Resin-modified Glass Ionomer Cement and Visible Light-cure Composite Bonding Material in Adult Orthodontic Patients - a Split-Mouth, Randomized Controlled Trial

NCT06602154 | Completed DMC

• 2 other identifiers: 2022-5282-23281Dr. Aleem Saeed Qureshi
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

In this split mouth study design, 34 orthodontic patients coming for fixed appliance treatment will be bonded with standard light-cure composite bonding material and intervention of Resin Modified Glass Ionomer Cement (RMGIC). Contralateral quadrants will be allocated randomly for either RMGIC or visible light-cure composite bonding in both upper and lower jaw. Quadrant 1: Randomly selected, contralateral upper and lower quadrants from central incisor to second premolar will be bonded with RMGIC bonding system. Quadrant 2: Randomly selected, contralateral quadrants from central incisor to second premolar will be bonded with visible light-cure composite bonding material. Allocation of diagonally opposite quadrants by either bonding system will be assigned randomly. Quadrants to be bonded with Resin-modified glass ionomer cement and light-cure composite bonding material will be switched from patient to patient to ensure randomization. This study is single blinded. The study investigators will not be blinded while the patient will be kept blinded. On the first visit, a specially designed consent form will be signed by the participant. Patient interaction for the purpose of study will only be for 1 hour duration while bonding of brackets. After six months amount and location of bond breakages will be evaluated from orthodontic record files. This study will help us evaluate bond strength of RMGIC as compared to light cure composite. RMGIC can also be considered as the choice of material for bonding in high risk caries patients.

Conditions

Orthodontics; Bracket Bonding; Malocclusion; Displaced or Missing Teeth

Keywords

Resin-modified glass ionomer cement; Light cure composite; bracket bonding

Outcome Measures

Primary Outcomes (1)

• Bracket bond failure

  The objective of this study is to compare rate of bond failures with Resin-modified glass ionomer cement and visible light-cure bonding.

  Three months

Study Arms (1)

Control group ( light cure composite )

ACTIVE COMPARATOR

Product: Denturum Light Cure Band Adhesive (Ortho Organizers). Composition: 4 mg composite adhesive paste and 6 ml Transbond primer. Storage: Stored at room temperature and protected from humidity. Usage: Steps for light -cure composite bonding are: 1. Prepare teeth with oil-free pumice, and rinse thoroughly for 15 seconds with water. 2. Air dry tooth surface for 5 seconds until dry field is maintained and isolate with cotton rolls. 3. Etch enamel surface with 37% phosphoric acid for 15 seconds. 4. Rinse the etched surface for 20 seconds to remove the acid and precipitates that might have formed during the etching procedure. 5. Thoroughly dry etched surface with moisture free air. Tooth surface should appear frosty white, if not than reetch for 5 seconds. 6. Brush thin uniform amount of primer on every tooth surface. 7. Apply a small amount of adhesive paste onto bracket base and position the bracket on tooth surface. 8. After accurately placing bracket on tooth surfac

Other: Resin modified glass ionomer

Interventions

Resin modified glass ionomer OTHER

The product will be stored by investigators at room temperature in lock and key. Product: Riva light cure RMGIC (HV) Composition: 18 mg orthodontic bonding paste and 6 ml enamel bond resin. Storage: Stored at room temperature and protected from humidity. Usage: Steps for Resin-modified glass ionomer cement composite bonding: 1. Prepare all teeth with oil-free pumice, and rinse thoroughly for 15 seconds with water. 2. Wash thoroughly. 3. Etch enamel surface with 37% phosphoric acid for 15 seconds. 4. Rinse the etched surface for 20 seconds to remove the acid and precipitates that might have formed during the etching procedure. 5. Activate the capsule and immediately mix in an amalgamator. Do not click with applicator before you mix. 6. Immediately place into capsule applicator and click trigger until paste is seen through the nozzle 7. Light cure each increment for 20 seconds.

Control group ( light cure composite )

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged between 12-35 years
• Patients with fair to good oral hygiene who have no significant sign of gingivitis
• Healthy patients with no co-morbids such as rheumatic fever, blood dyscrasias, congenital heart disease, or diabetes mellitus
• Patients with class I, II and III malocclusions

You may not qualify if:

• Enamel surface defects
• Pregnant patients or lactating mothers
• Syndromic patients
• Subjects with previous history of orthodontic

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (2)

Aga Khan University Hospital

Karachi, Sindh, 75500, Pakistan

Location

Aga Khan University Hospital

Karachi, Pakistan

Location

Related Publications (1)

• Qabool H, Qabool J, Sukhia RH, Fida M. Comparison of bond failure with resin-modified glass ionomer cement and visible light-cured composite bonding systems in orthodontic patients: A split-mouth randomized controlled trial. Dent Med Probl. 2024 Sep-Oct;61(5):651-657. doi: 10.17219/dmp/162970.

  PMID: 39364623 DERIVED

MeSH Terms

Conditions

Malocclusion; Anodontia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Program Director

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2021
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)